MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 40MM M SPEC+3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-43-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
(b)(6).Clinical notification received for revision due to metallosis.Date of implant: (b)(6) 2009, date of revision: (b)(6) 2021, (right hip).Treatment: revision of head and liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records operative notes were reviewed and indicated that on (b)(6) 2009, the patient underwent a right primary hip arthroplasty utilizing depuy synthes components with no intraoperative complications.On (b)(6) 2021, the patient underwent a right hip revision for adverse reaction to metal on metal debris.The hole eliminator, liner and head were revised.A large effusion ("brownish fluid"), a pseudocyst, trunnionosis, and lysis in the trochanter, around the sleeve and inferior to the cup was found requiring bone grafting.The posterior capsule was found to be atrophic.The surgeon remarks that there was no wear found on the head and liner and believes the metallosis occurred from the trunnion.The trunnion and morse taper were cleaned as much as possible before the new head was impacted.No product deficiency noted of the hole eliminator or reason for the revision of this product.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available patient x-rays were reviewed, and examination can not confirm the adverse event associated to the reported femoral head.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.It has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.

• Brand Name: 11/13 S-ROM 40MM M SPEC+3
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12521059
• Report Number: 1818910-2021-20948
• Device Sequence Number: 5146419
• Product Code: LPH
• UDI-Device Identifier: 10603295033776
• UDI-Public: 10603295033776
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1365-43-500
• Device Catalogue Number: 136543500
• Device Lot Number: 2937498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 10/20/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/05/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/13 S-ROM 40MM M SPEC+3; APEX HOLE ELIM POSITIVE STOP; PINNACLE MTL INS NEUT40IDX58OD; S-ROM*SLEEVE PRX ZTT, 20D-LRG; SROM STM STD 36+12L 15X20; UNKNOWN DEPUY CUP; 11/13 S-ROM 40MM M SPEC+3; APEX HOLE ELIM POSITIVE STOP; PINNACLE MTL INS NEUT40IDX58OD; S-ROM*SLEEVE PRX ZTT, 20D-LRG; SROM STM STD 36+12L 15X20; UNKNOWN DEPUY CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100